Motivational Interviewing for COVID-19 Vaccination

(REDES Trial)

Overseen By Adrianna Moore, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Previously participated, Lacks capacity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

900 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Motivational Interviewing for COVID-19 Vaccination?

Motivational interviewing (MI) has been shown to help people change behaviors in various health areas, like improving medication adherence for asthma and supporting lifestyle changes for chronic conditions. This suggests it could be effective in encouraging COVID-19 vaccination by helping people resolve their hesitations and increase their motivation to get vaccinated. ^{1 2 3 4 5}

Is Motivational Interviewing for COVID-19 Vaccination safe for humans?

The research articles reviewed do not provide specific safety data for Motivational Interviewing for COVID-19 Vaccination, but they discuss the general safety of placebo use in clinical trials, suggesting that placebos are generally safe and can be used effectively in various contexts. ^{6 7 8 9 10}

How does the treatment 'Control, REDES (Placebo, Standard Care)' for COVID-19 vaccination differ from other treatments?

This treatment is unique because it uses motivational interviewing, a technique that involves guided conversations to encourage people to get vaccinated, rather than a traditional medical intervention. It focuses on enhancing patient motivation and addressing vaccine hesitancy, which is different from other treatments that might involve medication or direct medical procedures. ^{8 9 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to find out which approach works better in getting more of the friends and connections of Latino adults get vaccinated against COVID-19. The main questions this study aims to answer are: 1. Can teaching people to use motivational interviewing help more friends and connections of Latino adults get the COVID-19 vaccine compared to just giving information about the vaccine? 2. What are the things that make it easier or harder for Latinos and networks to get the COVID-19 vaccine? 3. How does this intervention work in practice so that it can be made available to more people in the future The researchers will compare the vaccine rates of the friends and connections of Latinos who have been trained in motivational interviewing with those who have only been given information about the COVID-19 vaccine. This will help figure out which method works best to encourage more people to get vaccinated.

Research Team

Kathleen Page, MD

Principal Investigator

Johns Hopkins University

Cui Yang, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for Latino adults living in Maryland who are at least 18 years old and have had a COVID-19 vaccine or booster in the past year. Their friends and connections, also Latino and over 18, can join if they haven't been vaccinated or boosted within the last year. People who've already been in this study or can't consent aren't eligible.

Inclusion Criteria

I am 18 or older, identify as Hispanic/Latino, live in Maryland, and got a COVID-19 vaccine/booster in the last year.

Exclusion Criteria

Previously participated in the study

I am unable to understand or make decisions about my treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive training on motivational interviewing or information about the COVID-19 vaccine

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for vaccine uptake and intervention effectiveness

18 months

3 visits (in-person) at 6, 12, and 18 months

Treatment Details

Interventions

• Control
• REDES

Trial Overview The study tests whether teaching motivational interviewing to Latino adults helps their friends get vaccinated against COVID-19 more than just giving out vaccine information. It compares vaccination rates between those trained in this technique and those who only received info.

Participant Groups

Group I: REDES: Motivational interviewing training Experimental Treatment 1 Intervention

Participants in this arm will receive training on motivational interviewing (MI) to promote vaccine acceptance and uptake with their networks. The training will be led by community health workers on how to use MI to address vaccine hesitancy using a guiding approach, open-ended questions, affirmations, reflections, and summaries.

Group II: Control: COVID-19 vaccine information Active Control 1 Intervention

Participants in the control condition will receive a brief community health worker-led training about the safety and efficacy of the vaccine. Participants will have the opportunity to ask clarifying questions from the community health workers during the training.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Findings from Research

In a study of 47 participants, motivational interviewing (MI) sessions generally met quality benchmarks, particularly in making MI-consistent statements (100%) and complex reflections (85%), but struggled with using open-ended questions (19%).

Despite achieving good quality in MI sessions, there was no strong association between MI quality and adherence to antiretroviral therapy (ART), indicating that while MI can be effectively implemented, its impact on ART adherence may require further investigation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing to support antiretroviral therapy adherence: the role of quality counseling. Thrasher, AD., Golin, CE., Earp, JA., et al.[2019]

Motivational interviewing (MI) is an effective patient-centered counseling approach that enhances motivation for behavior change in patients, particularly those with asthma who may be resistant to following medical recommendations.

Integrating MI into clinical practice can improve patient retention and treatment outcomes without increasing time or costs, making it a practical strategy for healthcare providers to encourage medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief motivational interviewing as a clinical strategy to promote asthma medication adherence. Borrelli, B., Riekert, KA., Weinstein, A., et al.[2007]

A 12-week motivational counseling program significantly reduced weekly sitting time by 374 minutes and decreased depressive symptoms in Taiwanese women, indicating its effectiveness in promoting physical activity and mental well-being.

Participants in the motivational counseling group also experienced improvements in health-related quality of life across multiple dimensions compared to the usual care group, highlighting the program's comprehensive benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Counseling to Reduce Sedentary Behaviors and Depressive Symptoms and Improve Health-Related Quality of Life Among Women With Metabolic Syndrome. Chiang, LC., Heitkemper, MM., Chiang, SL., et al.[2020]

Motivational interviewing (MI) is a client-centered counseling approach that aims to promote behavior change, particularly in areas like diet and physical activity, and has its origins in addiction treatment.

While MI shows promise in helping patients make lifestyle changes, research results are mixed, indicating a need for further investigation into its implementation and effectiveness across different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? Coyne, N., Correnti, D.[2019]

A 2-day virtual training program in motivational interviewing (MI) for 30 clinicians from Veterans Affairs medical centers was effective, with participants reporting high satisfaction and confidence in applying new skills to their practice.

The virtual format of the training removed barriers such as travel and cost, making it particularly beneficial for clinicians in rural areas, and participants indicated they were actively using MI techniques three months after the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Synchronous Motivational Interviewing Training for Geographically Dispersed Interprofessional Learners. Bryan, JL., Saxon, LC., Mesidor, MM., et al.[2023]

The paper argues that short-term and long-term placebo effects operate through different mechanisms, with short-term effects driven by response expectancy and conditioning, while long-term effects are linked to goal satisfaction and its impact on the body's stress response systems.

This new theory suggests that understanding these differences can help enhance placebo effects and combine them with other psychological strategies to improve both short-term and long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivation and placebos: do different mechanisms occur in different contexts? Hyland, ME.[2021]

The Placebo-Control Reminder Script (PCRS) effectively reduced the placebo response in participants with major depressive or psychotic disorders, leading to smaller reductions in depression symptoms compared to those who did not receive the script, with a medium effect size (Cohen's d = 0.40).

Participants who received the PCRS also experienced fewer adverse events, indicating that educating participants about placebo responses can not only reduce placebo effects but also minimize potential nocebo effects during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response mitigation with a participant-focused psychoeducational procedure: a randomized, single-blind, all placebo study in major depressive and psychotic disorders. Cohen, EA., Hassman, HH., Ereshefsky, L., et al.[2021]

Placebo-controlled trials are valuable for their high internal validity, helping to ensure that the effects observed are due to the treatment itself rather than other factors, but they may not always translate well to real-world clinical practice.

Using placebos can complicate the estimation of treatment effects and may not provide useful information for making real-world clinical decisions, highlighting the need for careful consideration when designing trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why use placebos in clinical trials? A narrative review of the methodological literature. Vickers, AJ., de Craen, AJ.[2019]

In psychotherapy, well-designed psychological placebos can be as effective as established psychotherapies, suggesting that the context and design of treatment play a crucial role in outcomes.

For psychological disorders like depression, pill placebos can be nearly as effective as active medications, highlighting the significant impact of placebo effects in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo is powerful: estimating placebo effects in medicine and psychotherapy from randomized clinical trials. Wampold, BE., Minami, T., Tierney, SC., et al.[2007]

In a study of 102 healthy participants, those who received open label placebos (OLPs) with information about their benefits (OLP-plus) showed increased well-being, particularly when their baseline well-being was low, highlighting the importance of context and information in placebo effects.

The OLP-plus group had higher expectations about the treatment's effectiveness, which helped improve their physical symptoms compared to the control group, suggesting that providing rationale can enhance the efficacy of OLPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of positive information provision in open-label placebo effects. Barnes, K., Babbage, E., Barker, J., et al.[2023]

The study discusses various clinical trial designs aimed at enhancing the understanding of drug-placebo differences, focusing on ethical considerations, patient motivation, and the impact of placebo and nocebo effects on treatment outcomes.

It highlights the importance of balancing the beneficial aspects of the placebo response in patient care while controlling for its potential confounding effects during drug development, which is crucial for accurate efficacy assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional and innovative experimental and clinical trial designs and their advantages and pitfalls. Weimer, K., Enck, P.[2014]

Historical placebo data from randomized control trials (RCTs) can be a valuable resource for drug developers, potentially reducing patient burden and speeding up drug discovery processes.

However, challenges such as differences in trial design, patient characteristics, and unmeasured factors must be addressed to effectively utilize these historical controls in future RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Historical Controls in Randomized Clinical Trials: Opportunities and Challenges. Hall, KT., Vase, L., Tobias, DK., et al.[2021]

Placebo controls in clinical trials are ethically acceptable under specific conditions, such as when there is no effective treatment available or when withholding treatment poses minimal risk to participants.

The article emphasizes the importance of 'methodological reasons' for using placebos, particularly in cases where the research aims to develop interventions for the same population, ensuring that ethical standards are maintained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ethics of placebo-controlled trials: methodological justifications. Millum, J., Grady, C.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Motivational interviewing to support antiretroviral therapy adherence: the role of quality counseling. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Brief motivational interviewing as a clinical strategy to promote asthma medication adherence. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Motivational Counseling to Reduce Sedentary Behaviors and Depressive Symptoms and Improve Health-Related Quality of Life Among Women With Metabolic Syndrome. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Virtual Synchronous Motivational Interviewing Training for Geographically Dispersed Interprofessional Learners. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Motivation and placebos: do different mechanisms occur in different contexts? [2021]

7. England pubmed.ncbi.nlm.nih.gov

Placebo response mitigation with a participant-focused psychoeducational procedure: a randomized, single-blind, all placebo study in major depressive and psychotic disorders. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Why use placebos in clinical trials? A narrative review of the methodological literature. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The placebo is powerful: estimating placebo effects in medicine and psychotherapy from randomized clinical trials. [2007]

10. England pubmed.ncbi.nlm.nih.gov

The role of positive information provision in open-label placebo effects. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Traditional and innovative experimental and clinical trial designs and their advantages and pitfalls. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Historical Controls in Randomized Clinical Trials: Opportunities and Challenges. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

The ethics of placebo-controlled trials: methodological justifications. [2021]